I think the main risk here is wondering what FDA will say about the data or any requests made before data submission. Linda said they were in ongoing discussions with FDA and the crossover complicated OS readouts so.. once the data was submitted there was a new risk to acknowledge. Data was submitted in October apparently so the report needed to disclose any new known risk since the previous report. This risk includes regulator decision making based on complicated OS results which are now awaiting statistically significant separation and quantity to occur. This would reflect the early vs late treatment comment Dr. Linda Liau made.
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